|Over a week ago|
TG Therapeutics announces preclinical data for TG-1701 » 09:1806/2206/22/20
TG Therapeutics announced…
TG Therapeutics announced preclinical data presentation for TG-1701, the Company's highly selective, BTK inhibitor, at the 2020 American Association for Cancer Research annual meeting, being held virtually. Title: TG-1701, a novel irreversible Bruton's kinase inhibitor, does not inhibit anti-CD20-driven ADCC and ADCP in vitro, and cooperates with the glycoengineered anti-CD20 mAb, ublituximab, in in vivo mantle cell lymphoma models: In vitro and in vivo studies were undertaken to evaluate the activity of TG-1701 alone and in combination with ublituximab and umbralisib in models of lymphoma: TG-1701 showed greater selectivity for BTK than, and similar activity to, ibrutinib in mantel cell lymphoma models; TG-1701, in contrast to ibrutinib, did not block ublituximab-driven antibody-dependent cellular cytotoxicity or antibody-dependent cell phagocytosis in vitro; In vivo xenograft studies suggested that TG-1701 synergized with the U2 combination, resulting in greater anti-tumor activity than either TG-1701 or U2 alone.
TG Therapeutics completes rolling submission of NDA for umbralisib » 07:0406/1706/17/20
TG Therapeutics announced…
TG Therapeutics announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration requesting accelerated approval of umbralisib, the Company's investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma and follicular lymphoma. The FDA previously granted umbralisib breakthrough therapy designation for MZL and orphan drug designation for MZL and FL. The UNITY- NHL trial is a multicenter, open-label Phase 2b trial. The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. In February of 2019, the Company announced that the primary endpoint of overall response rate as determined by Independent Review Committee was met for all treated MZL patients. The results met the Company's target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort were presented in oral presentations in 2019 at the American Association for Cancer Research annual meeting, the American Society of Clinical Oncology annual meeting and the International Conference on Malignant Lymphoma. The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who have received at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. In October of 2019, the Company announced that the primary endpoint of ORR as determined by IRC was met for all treated FL patients. The results met the Company's prespecified response target of 40-50% ORR.
TG Therapeutics data presentations at EHA 'compelling,' says H.C. Wainwright » 11:1906/1206/12/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Edward White noted that TG Therapeutics announced presentations at the European Hematology Association, or EHA, annual congress with data that he described as "compelling." The analyst, who said he continues to expect TG-1701 to be "an important component of a wholly-owned triplet therapy," keeps a Buy rating and $32 price target on TG Therapeutics shares.
TG Therapeutics announces data presentations at EHA Annual Congress » 07:1506/1206/12/20
TG Therapeutics announced…
TG Therapeutics announced data presentations at the 25th European Hematology Association annual congress including data from a Phase 1 study evaluating TG-1701, the Company's once daily, selective, BTK inhibitor, as monotherapy and in combination with umbralisib and ublituximab in relapsed/refractory chronic lymphocytic leukemia and lymphoma, as well as long term data from a Phase 1/1b study evaluating the combination of umbralisib and ibrutinib in relapsed/refractory CLL and mantle cell lymphoma. Presentation Title: Safety and activity of the once daily selective bruton tyrosine kinase inhibitor TG-1701 in patients with chronic lymphocytic leukemia and lymphoma: This presentation includes interim data from a Phase 1 parallel dose-escalation study of TG-1701 monotherapy and TG-1701 in combination with U2 in 82 patients with relapsed/refractory B-cell malignancies. Sixty-nine patients were treated with single agent TG-1701, of which 25 patients were treated in the monotherapy dose escalation portion of the study and received TG-1701 at doses that ranged from 100mg to 400mg once daily, and 44 patients were treated with 200mg of TG-1701 in the monotherapy dose expansion cohort. An additional 13 patients were treated in the TG-1701 plus U2 dose escalation portion of the study. Safety and efficacy highlights include: TG-1701 monotherapy exhibited an encouraging preliminary safety profile across all dose levels evaluated with only 3% of patients having a dose reduction due to treatment-related adverse events, with no treatment discontinuations due to AEs in the monotherapy cohorts. In the monotherapy dose escalation cohort, TG-1701 produced partial responses at all dose levels evaluated in CLL, MCL, Waldenstrom's macroglobulinemia, and small lymphocytic lymphoma. In the monotherapy dose expansion cohort in which TG-1701 was administered at 200mg, 25 patients were evaluable for efficacy with a 92% overall response rate observed in CLL patients, a 33% ORR in MCL patients, and a 86% ORR in WM patients. The combination of TG-1701 plus U2 has been well tolerated and demonstrated encouraging clinical activity with a 77% ORR across all disease types, including complete responses in three patients; dose escalation continues. Presentation Title: Long term results of a Phase I/Ib study of ibrutinib in combination with umbralisib in patients with relapsed/refractory CLL or MCL: This presentation includes updated long term data from a Phase 1/1b study of patients with relapsed or refractory CLL or MCL treated with umbralisib in combination with ibrutinib. Data from this trial were previously published in Lancet Haematology in December 2018. As of the updated data cutoff, 42 patients were evaluable for safety and efficacy. Safety and efficacy highlights include: With long term follow up median follow-up of 43.5 months, there were no cumulative or recurrent late onset toxicities observed. In relapsed/refractory CLL, the overall response rate was 95% including a 29% complete response rate, and the 4-year Progression-free Survival and Overall Survival were 78% and 90%, respectively In relapsed/refractory MCL, the ORR was 71% with a 24% CR rate, and median PFS and OS were 10.8 and 30.7 months, respectively.
|Over a month ago|
TG Therapeutics announces final results of GENUINE Phase 3 study » 08:5105/2905/29/20
TG Therapeutics announced…
TG Therapeutics announced the final results from the GENUINE Phase 3 study evaluating the combination of ublituximab, the Company's novel glycoengineered anti-CD20 monoclonal antibody, plus ibrutinib compared to ibrutinib alone in patients with previously treated high-risk chronic lymphocytic leukemia at the 56th American Society of Clinical Oncology annual meeting. Details of the data presentation are included below. Presentation Title: Effect of Adding Ublituximab to Ibrutinib on PFS, ORR, and MRD Negativity in Previously Treated High-Risk Chronic Lymphocytic Leukemia: Final Results of the GENUINE Phase III Study : The GENUINE trial is an open-label, multicenter, randomized, Phase III study in relapsed or refractory high-risk CLL. This presentation includes data from 117 patients treated with either ublituximab plus ibrutinib or ibrutinib alone. As of the cut-off date of September 1, 2019, patients had a median follow-up time of 41.9 months. The primary endpoint for this trial was overall response rate as determined by an independent review committee. The secondary endpoints included progression free survival and complete response rate as determined by an IRC, and undetectable minimal residual disease assessed by central lab. Efficacy and safety highlights include: The addition of ublituximab to ibrutinib compared to ibrutinib monotherapy significantly improved ORR, complete response/complete response with incomplete blood count recovery rate, and increased rates of uMRD in patients with relapsed/refractory CLL with high-risk cytogenetics. At a median follow-up of 41.9 months, median PFS was not reached in the ublituximab plus ibrutinib arm and was 35.9 months in the ibrutinib monotherapy arm, with del17p/TP53mut patients seeing the greatest difference in PFS. The addition of ublituximab to ibrutinib did not significantly alter the known safety profile of ibrutinib however the combination resulted in slightly higher rates of neutropenia and atrial fibrillation.
TG Therapeutics price target raised to $37 from $29 at B. Riley FBR » 08:5005/1805/18/20
B. Riley FBR analyst…
B. Riley FBR analyst Mayank Mamtani raised the firm's price target on TG Therapeutics to $37 from $29 and keeps a Buy rating on the shares. The analyst has increased conviction in ublituximab's value across the oncology and multiple sclerosis franchises. Further, TG's strengthened balance sheet removes a key stock overhang, Mamtani tells investors in a research note.
TG Therapeutics price target raised to $37 from $29 at B. Riley FBR » 20:1705/1705/17/20
B. Riley FBR analyst…
B. Riley FBR analyst Mayank Mamtani raised the firm's price target on TG Therapeutics to $37 from $29 and keeps a Buy rating on the shares. The analyst has increased conviction in the valuation of ublituximab.
Unusually active option classes on open May 15th » 09:4005/1505/15/20
SRNE, MT, RIO, TGTX, SLV, DKNG, QCOM, GSX, GDXJ, OXY
Unusual total active…
Unusual total active option classes on open include: Sorrento Therapeutics (SRNE), ArcelorMittal (MT), Rio Tinto (RIO), TG Therapeutics (TGTX), iShares Silver Trust (SLV), DKNG (DKNG), Qualcomm (QCOM), GSX Techedu (GSX), GDXJ (GDXJ), and Occidental Petroleum (OXY).
TG Therapeutics 6M share Spot Secondary priced at $18.00 » 05:5805/1505/15/20
The deal size was…
The deal size was increased to 8.5M shares from 6M shares and priced at the bottom of the $18.00-$19.00 range. JPMorgan, Jefferies, Evercore ISI and Cantor Fitzgerald acted as joint book running managers for the offering.
Fly Intel: After-Hours Movers » 19:1105/1405/14/20
YTEN, OPRT, DENN, ACB, AEYE, NEWR, DDS, AMAT, GLOB, OCUL, REGN, CODX, FTCH, CVET, ETON, AUPH, VVI, TGTX
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